FDA Device Establishments · JSON-LD · Markdown
FEI 3028746593 · Repack or Relabel Medical Device Reprocess Single-Use Device Remanufacture Medical Device · Status: Active
| FEI Number | 3028746593 |
|---|---|
| Owner / Operator | Bioteke USA LLC (#10088753) |
| Address | 900 Brickell Key Blvd Suite 2304, Miami, FL, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 1 |
| Product codes (top 20) | QKP |
| Proprietary names | Bio-Self COVID-19 Antigen Home Test |
Source: openFDA. Public-domain (CC0).